Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy

Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy - TAO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35026

Enrollment

145

Registered

2010-02-23

Start date

2010-11-22

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(imminent) Myocardial Infarction Acute Coronary Syndrome

Interventions

Patients will be divided into two medication arms. Patients will receive intravenous infusion of otamixaban and placebos or an intravenous infusion of UFH (plus eptifibatide in case of a PCI) and pl

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient with non ST-segment elevation Acute Coronary Syndrome with the following symptoms: - Ischemic symptoms (chest pain or equivalent) at rest >=10 minutes within 24 hours of randomization -One of the two following criteria: *New ST-segment depression >=0.1 mV (>=1 mm), or transient (=0.1 mV (>=1 mm) in at least 2 contiguous leads on the ECG, OR *Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal - Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified)

Exclusion criteria

Exclusion criteria: 7.3.1.1 General - High likelihood of being unavailable for the Day 180 follow up - Age

Design outcomes

Primary

Measure	Time frame
All-cause death + Myocardial infarction from randomization to day 7.	—

Secondary

Measure	Time frame
- All-cause death + myocardial infarction + any stroke from randomization to day 7 - Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia / myocardial infarction from randomization to day 30 - All cause death from randomization to day 30 - Safety of otamixaban as compared to UFH + eptifibatide - Procedural thrombotic complications during the index PCI	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)